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This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of IBI362 in MASH subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 8-week screening period, a 60-week double-blind treatment period, and a 4-week follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI362 Low Dose | Experimental | Dose level 1,SC,once a week for 4 weeks; Dose level 2,SC,once a week for 4 weeks; Dose level 3,SC,once a week for 52 weeks |
|
| IBI362 High Dose | Experimental | Dose level 1,SC,once a week for 4 weeks; Dose level 2,SC,once a week for 4 weeks; Dose level 3,SC,once a week for for 4 weeks; Dose level 4,SC,once a week for 48 weeks |
|
| Placebo | Placebo Comparator | Placebo,SC,once a week for 60 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo administered subcutaneously (SC) once a week. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology | Baseline, Week 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology | Baseline, Week 60 | |
| Percentage of Participants With MASH improvement With no Worsening of Fibrosis on Liver Histology | Baseline, Week 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Wei | Contact | 0512-69566088 | jie.wei@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgung Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| C000719829 | mazdutide |
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| IBI362 |
| Drug |
IBI362 administered subcutaneously (SC) once a week. |
|
| Percentage of Participants With MASH improvement With ≥1 Point Decrease in Fibrosis Stage on Liver Histology | Baseline, Week 60 |
| Percentage of Participants With MASH resolution With ≥1 Point Decrease in Fibrosis Stage on Liver Histology | Baseline, Week 60 |
| Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage on Liver Histology | Baseline, Week 60 |
| Mean Absolute Change and Percentage Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) | Baseline, Week 4, Week 12, Week 36, Week 60 |
| Percentage of participants with at least 30%, 50% and 70% relative reduction in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) From Baseline | Baseline, Week 4, Week 12, Week 36, Week 60 |
| Mean Absolute Change and Percentage change From Baseline in aspartate aminotransferase[U/L] | Baseline, Week 36, Week 60 |
| Mean Absolute Change and Percentage change From Baseline in alanine aminotransferase[U/L] | Baseline, Week 36, Week 60 |
| Mean Absolute Change and Percentage change From Baseline in a γ-Glutamyl transferase[U/L] | Baseline, Week 36, Week 60 |
| Mean Absolute Change and Percentage change From Baseline in triglyceride [mmol/L] | Baseline, Week 36, Week 60 |
| Mean Absolute Change and Percentage change From Baseline in total cholesterol[mmol/L] | Baseline, Week 36, Week 60 |
| Mean Absolute Change and Percentage change From Baseline in low-density lipoprotein cholesterol[mmol/L] | Baseline, Week 36, Week 60 |
| Mean Absolute Change and Percentage change From Baseline in high-density lipoprotein cholesterol[mmol/L] | Baseline, Week 36, Week 60 |
| Mean Absolute Change and Percent Change from Baseline in Body Weight [kg] | Baseline, Week 36, Week 60 |
| Percentage of Participants who Achieve ≥5%, ≥10% and ≥15% Body Weight Reduction | Baseline, Week 36, Week 60 |
| Mean Absolute Change from Baseline in BMI [kg/m2] | Baseline, Week 36, Week 60 |
| Mean Absolute Change from Baseline in Waist Circumference [cm] | Baseline, Week 36, Week 60 |
| Mean Absolute Change from Baseline in Fasting Plasma Glucose (FPG )[mmol/L | Baseline, Week 36, Week 60 |
| Mean Absolute Change from Baseline in Fasting Blood Insulin[mlU/L] | Baseline, Week 36, Week 60 |
| Mean Absolute Change from Baseline in glycated hemoglobin A1c (HbA1c)[%] | Baseline, Week 36, Week 60 |
| Change from Baseline in Homeostasis Model Assessment IR | Baseline, Week 36, Week 60 |
| Changes from baseline in scores in 36-item Short-Form Health Survey version 2(SF-36v2) | The SF-36 is a 36 item questionnaire that measures eight multi-item dimensions of health. For each dimension item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state) | Baseline, Week 36, Week 60 |
| Change from baseline in scores in NASH-CHECK (patient-reported outcome measure for non-alcoholic steatohepatitis) | NASH-CHECK scores range from 0 to 10, with higher scores indicating worse symptoms/HRQOL | Baseline, Week 36, Week 60 |
| Change from baseline in scores in PGI-SPatient Global Impression of Severity（PGI-S） | 6-point Patient Global Impression of Severity of NASH symptoms (PGIS; 7-day recall period; responses ranging from "no symptoms" to "very severe"). | Baseline, Week 36, Week 60 |
| The proportion of subjects with at least a 25% improvement in liver stiffness measurement (LSM) relative to baseline based on FibroScan and FibroTouch measurements, and the proportion of subjects with at least a 30% improvement in controlled attenuation | Baseline, Week 36, Week 60 |